DE69604009D1 - Stable liquid composition containing urate oxidase and lyophilized composition for its manufacture - Google Patents

Stable liquid composition containing urate oxidase and lyophilized composition for its manufacture

Info

Publication number
DE69604009D1
DE69604009D1 DE69604009T DE69604009T DE69604009D1 DE 69604009 D1 DE69604009 D1 DE 69604009D1 DE 69604009 T DE69604009 T DE 69604009T DE 69604009 T DE69604009 T DE 69604009T DE 69604009 D1 DE69604009 D1 DE 69604009D1
Authority
DE
Germany
Prior art keywords
urate oxidase
manufacture
stable liquid
composition containing
liquid composition
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
DE69604009T
Other languages
German (de)
Other versions
DE69604009T2 (en
Inventor
Claude Aleman
Alain Bayol
Thierry Breul
Patrice Dupin
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi Aventis France
Original Assignee
SANOFI PARIS
Sanofi SA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by SANOFI PARIS, Sanofi SA filed Critical SANOFI PARIS
Application granted granted Critical
Publication of DE69604009D1 publication Critical patent/DE69604009D1/en
Publication of DE69604009T2 publication Critical patent/DE69604009T2/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43—Enzymes; Proenzymes; Derivatives thereof
    • A61K38/44—Oxidoreductases (1)
    • A61K38/443—Oxidoreductases (1) acting on CH-OH groups as donors, e.g. glucose oxidase, lactate dehydrogenase (1.1)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/06—Antigout agents, e.g. antihyperuricemic or uricosuric agents

Abstract

Pharmaceutically acceptable, physically stable, liq. compsn. comprises urate oxidase and 0.1-10 mg/ml Poloxamer 188 (polyoxyethylene / polyoxypropylene copolymer) in a buffered aq. medium. Also claimed is a freeze-dried compsn. contg. Poloxamer 188 and urate oxidase in a wt. ratio of 0.01-50:1 respectively.
DE69604009T 1995-05-11 1996-05-09 Stable liquid composition containing urate oxidase and lyophilized composition for its manufacture Expired - Lifetime DE69604009T2 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR9505606A FR2733914B1 (en) 1995-05-11 1995-05-11 STABLE LIQUID COMPOSITION CONTAINING URATE OXYDASE AND LYOPHILIZED COMPOSITION FOR ITS PREPARATION
US08/644,163 US5811096A (en) 1995-05-11 1996-05-10 Stable liquid composition containing urate oxidase and lyophilized composition for its preparation

Publications (2)

Publication Number Publication Date
DE69604009D1 true DE69604009D1 (en) 1999-10-07
DE69604009T2 DE69604009T2 (en) 2000-04-06

Family

ID=26231954

Family Applications (1)

Application Number Title Priority Date Filing Date
DE69604009T Expired - Lifetime DE69604009T2 (en) 1995-05-11 1996-05-09 Stable liquid composition containing urate oxidase and lyophilized composition for its manufacture

Country Status (24)

Country Link
US (1) US5811096A (en)
EP (1) EP0742013B1 (en)
JP (1) JP2950775B2 (en)
CN (1) CN1090972C (en)
AT (1) ATE183925T1 (en)
AU (1) AU710288B2 (en)
BR (1) BR1100337A (en)
CA (1) CA2175971C (en)
CZ (1) CZ290799B6 (en)
DE (1) DE69604009T2 (en)
DK (1) DK0742013T3 (en)
EA (1) EA000024B1 (en)
ES (1) ES2137635T3 (en)
FR (1) FR2733914B1 (en)
GR (1) GR3031896T3 (en)
HU (1) HU225147B1 (en)
IL (1) IL118171A (en)
NO (1) NO315261B1 (en)
NZ (1) NZ286554A (en)
PL (1) PL184135B1 (en)
SG (1) SG42355A1 (en)
SI (1) SI0742013T1 (en)
TW (1) TW420614B (en)
ZA (1) ZA963683B (en)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030166525A1 (en) * 1998-07-23 2003-09-04 Hoffmann James Arthur FSH Formulation
US6783965B1 (en) * 2000-02-10 2004-08-31 Mountain View Pharmaceuticals, Inc. Aggregate-free urate oxidase for preparation of non-immunogenic polymer conjugates
DK2158923T3 (en) 1998-08-06 2013-03-25 Mountain View Pharmaceuticals Peg urate oxidase conjugates and their use
FR2782455B3 (en) * 1998-08-20 2000-09-15 Sanofi Sa INJECTABLE PHARMACEUTICAL COMPOSITION BASED ON A PHARMACEUTICALLY ACCEPTABLE SALT OF CLOPIDOGREL OR TICLOPIDINE
US8765124B2 (en) * 2003-02-28 2014-07-01 Chugai Seiyaku Kabushiki Kaisha Stabilized preparation containing protein
DK1610822T4 (en) 2003-04-02 2019-01-14 Ares Trading Sa Liquid pharmaceutical FSH and LH formulations together with a nonionic surfactant
WO2004112826A1 (en) * 2003-06-20 2004-12-29 Ares Trading Sa Freeze-dried fsh / lh formulations
PT3321359T (en) 2005-04-11 2021-03-11 Horizon Pharma Rheumatology Llc Variant forms of urate oxidase and use thereof
CN101194016B (en) 2005-04-11 2012-09-05 萨文特医药公司 A variant form of urate oxidase and use thereof
US8148123B2 (en) * 2005-04-11 2012-04-03 Savient Pharmaceuticals, Inc. Methods for lowering elevated uric acid levels using intravenous injections of PEG-uricase
US20080159976A1 (en) * 2005-04-11 2008-07-03 Jacob Hartman Methods for lowering elevated uric acid levels using intravenous injections of PEG-uricase
CN1864744B (en) * 2005-05-18 2010-09-29 杭州北斗生物技术有限公司 Pharmaceutical preparation containing urate oxidase
EP1883425A1 (en) * 2005-05-23 2008-02-06 Universite De Geneve Injectable superparamagnetic nanoparticles for treatment by hyperthermia and use for forming an hyperthermic implant
HU230758B1 (en) 2006-04-12 2018-03-28 Crealta Pharmaceuticals LLC 100% Purification of proteins with cationic surfactant
CA2766309A1 (en) 2009-06-25 2010-12-29 Savient Pharmaceuticals, Inc. Methods and kits for predicting infusion reaction risk and antibody-mediated loss of response by monitoring serum uric acid during pegylated uricase therapy
CN105412942B (en) * 2015-12-23 2019-02-26 沈阳三生制药有限责任公司 The recombination candida utili urate oxidase freeze dried injection of Pegylation
WO2017180594A1 (en) * 2016-04-13 2017-10-19 Medimmune, Llc Use of amino acids as stabilizing compounds in pharmaceutical compositions containing high concentrations of protein-based therapeutic agents
KR101744900B1 (en) 2017-01-20 2017-06-08 주식회사 대웅 Stable Liquid Composition Comprising Botulinum Toxin

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3928137A (en) * 1971-10-20 1975-12-23 Mallinckrodt Inc Reagent formulation for uric acid assay
US3997470A (en) * 1971-10-20 1976-12-14 Mallinckrodt, Inc. Surfactant containing reagent formulations for assaying biological specimens and methods of preparing same
JPS51104807A (en) * 1975-03-12 1976-09-17 Hitachi Ltd Teepurekoodano ootoribaasuseigyokairo
JPS5417027A (en) * 1977-07-07 1979-02-08 Canon Inc Image forming system
DE3126759A1 (en) * 1981-07-07 1983-01-27 Boehringer Mannheim Gmbh, 6800 Mannheim SOLUBLE LIVER URICASE, METHOD FOR THE PRODUCTION AND USE THEREOF
JPS60224499A (en) * 1984-04-23 1985-11-08 Toyobo Co Ltd Stable pharmaceutical preparation of uricase
DE3743405A1 (en) * 1987-05-14 1988-11-24 Boehringer Mannheim Gmbh METHOD FOR DETERMINING FRUCTOSAMINE
JPH0243471A (en) * 1988-08-03 1990-02-14 Iwataro Moriyama Three-dimensional parking device

Also Published As

Publication number Publication date
DE69604009T2 (en) 2000-04-06
EA199600024A3 (en) 1997-03-31
JPH0925242A (en) 1997-01-28
FR2733914B1 (en) 1997-08-01
CZ290799B6 (en) 2002-10-16
EP0742013A1 (en) 1996-11-13
MX9601756A (en) 1997-07-31
CN1147961A (en) 1997-04-23
HUP9601241A2 (en) 1997-04-28
HU225147B1 (en) 2006-07-28
AU710288B2 (en) 1999-09-16
IL118171A0 (en) 1996-09-12
DK0742013T3 (en) 2000-03-06
ATE183925T1 (en) 1999-09-15
NO315261B1 (en) 2003-08-11
NZ286554A (en) 1998-09-24
EA000024B1 (en) 1997-12-30
JP2950775B2 (en) 1999-09-20
ES2137635T3 (en) 1999-12-16
HU9601241D0 (en) 1996-07-29
NO961915L (en) 1996-11-12
TW420614B (en) 2001-02-01
BR1100337A (en) 2000-07-25
EA199600024A2 (en) 1996-12-30
US5811096A (en) 1998-09-22
CA2175971C (en) 2003-12-30
SG42355A1 (en) 1997-08-15
PL314147A1 (en) 1996-11-12
CA2175971A1 (en) 1996-11-12
SI0742013T1 (en) 1999-12-31
GR3031896T3 (en) 2000-02-29
IL118171A (en) 2000-08-31
PL184135B1 (en) 2002-09-30
ZA963683B (en) 1997-11-10
CN1090972C (en) 2002-09-18
EP0742013B1 (en) 1999-09-01
FR2733914A1 (en) 1996-11-15
AU5213996A (en) 1996-11-21
HUP9601241A3 (en) 2000-06-28
CZ135096A3 (en) 1996-12-11
NO961915D0 (en) 1996-05-10

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Legal Events

Date Code Title Description
8364 No opposition during term of opposition
8327 Change in the person/name/address of the patent owner

Owner name: SANOFI-SYNTHELABO, PARIS, FR

8327 Change in the person/name/address of the patent owner

Owner name: SANOFI-AVENTIS, PARIS, FR

R082 Change of representative

Ref document number: 742013

Country of ref document: EP

Representative=s name: TER MEER STEINMEISTER & PARTNER GBR PATENTANWA, DE